Responsibilities:
- Perform analysis work according to SOPs and guidance.
- Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods.
- Manage lab logistics, including purchasing, inventory control, and payment processing.
- Maintain instruments and ensure cleanliness and maintenance of the workspace.
- Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting.
- Attend training courses related to CAP/GCP/GLP/regulatory requirements.
Study Based Responsibility (if needed)
Analytical Study Director in Study
- Work as the Study Director, responsible for the overall conduct and final report of the study.
- Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies.
- Make study plans, amendments, and SOPs available to study personnel.
- Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary.
- Document and record all generated raw data.
- Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion.
Study Personnel in Study
- Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice.
- Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations.
- Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.
Qualifications:
Education and Experience:
-
A 4-year BS (Bachelor of Science) degree in Biochemistry, Biotechnology and
Laboratory Science, Chemistry, or a related field. Or Junior colleague with over 3-year lab
work experience and well qualified. Advanced degree is a plus for Associate Researcher/
Senior Researcher.
Skills and Competencies:
- Familiar with all lab operation activities.
- Excellent working knowledge of CAP/GCP, applicable law (local and country) and regulatory requirements.
- Good communication skills.
- Good verbal and written English or other second language skills.
- Good problem-solving skills.
- Effective time management and prioritization skills.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
